Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals, Inc. announced that the companies have received marketing approval for Relistor (methylnaltrexone bromide) subcutaneous injection from the European Commission.
According to a Wyeth press release, Relistor is now approved in the 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein for the treatment of opioid-induced constipation (OIC) in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. Relistor is the first approved treatment for OIC in the European Union.
"The approval of Relistor by the European Commission is another major milestone for this innovative therapy, the first medicine approved for the treatment of opioid-induced constipation in advanced illness patients," says Paul J. Maddon, M.D., Ph.D., founder, chief executive officer and chief science officer of Progenics. "Approval in Europe significantly extends the availability of Relistor for advanced illness patients receiving palliative care who experience opioid-induced constipation, a potentially debilitating side effect of opioid therapy."
Joseph M. Mahady, president, Wyeth Pharmaceuticals, says: "We are proud to be able to offer this new innovation to physicians and health care providers caring for palliative care patients with advanced illness. We are pleased to have received regulatory approvals for Relistor from Canada, the United States, and Europe in quick succession, as they represent significantly developed markets for opioid use in palliative care patients."
Commercial launch of Relistor in Europe will be rolled out on a country-by-country basis, with the first launch anticipated to occur later this month.
Relistor, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. Each year, more than 1.5 million Americans receive palliative care due to an advanced illness, such as incurable cancer and other end-stage diseases. Similar figures are not available for Europe as a whole.
On April 24, 2008, the United States Food and Drug Administration approved Relistor subcutaneous injection for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The use of Relistor beyond four months has not been studied. Relistor was made available in the United States on June 2, 2008. On March 28, 2008, this form of Relistor was approved by Health Canada and was launched on May 27, 2008. A marketing application for subcutaneous Relistor was submitted to the Australian Therapeutic Goods Administration in August 2007 and is under review. Other applications in additional countries are also pending.